title: Comparison of predictors for high-grade cervical intraepithelial neoplasia in women with abnormal smears.
abstract: BACKGROUND
  The detection of high-risk human papillomavirus (HPV) DNA provides higher sensitivity but lower specificity than cytology for the identification of high-grade cervical intraepithelial neoplasia (CIN). This study compared the sensitivity and specificity of several adjunctive tests for the detection of high-grade CIN in a population referred to colposcopy because of abnormal cytology.
  
  
  METHODS
  953 women participated in the study. Up to seven tests were carried out on a liquid PreservCyt sample: Hybrid Capture II (Digene), Amplicor (Roche), PreTect HPV-Proofer (NorChip), APTIMA HPV assay (Gen-Probe), Linear Array (Roche), Clinical-Arrays (Genomica), and CINtec p16INK4a Cytology (mtm Laboratories) immunocytochemistry. Sensitivity, specificity, and positive predictive value (PPV) were based on the worst histology seen on either the biopsy or the treatment specimen after central review.
  
  
  RESULTS
  273 (28.6%) women had high-grade disease (CIN2+) on worst histology, with 193 (20.2%) having CIN3+. For the detection of CIN2+, Hybrid Capture II had a sensitivity of 99.6%, specificity of 28.4%, and PPV of 36.1%. Amplicor had a sensitivity of 98.9%, specificity of 21.7%, and PPV of 33.5%. PreTect HPV-Proofer had a sensitivity of 73.6%, specificity of 73.1%, and PPV of 52.0%. APTIMA had a sensitivity of 95.2%, specificity of 42.2%, and PPV of 39.9%. CINtec p16INK4a Cytology had a sensitivity of 83.0%, specificity of 68.7%, and PPV of 52.3%. Linear Array had a sensitivity of 98.2%, specificity of 32.8%, and PPV of 37.7%. Clinical-Arrays had a sensitivity of 80.9%, specificity of 37.1%, and PPV of 33.0%.
authors.affiliation: Cancer Research UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, London EC1M 6BQ, United Kingdom. anne.szarewski@cancer.org.uk
authors.forename: Anne
authors.initials: A
authors.lastname: Szarewski
authors.forename: Laurence
authors.initials: L
authors.lastname: Ambroisine
authors.forename: Louise
authors.initials: L
authors.lastname: Cadman
authors.forename: Janet
authors.initials: J
authors.lastname: Austin
authors.forename: Linda
authors.initials: L
authors.lastname: Ho
authors.forename: George
authors.initials: G
authors.lastname: Terry
authors.forename: Stuart
authors.initials: S
authors.lastname: Liddle
authors.forename: Roberto
authors.initials: R
authors.lastname: Dina
authors.forename: Julie
authors.initials: J
authors.lastname: McCarthy
authors.forename: Hilary
authors.initials: H
authors.lastname: Buckley
authors.forename: Christine
authors.initials: C
authors.lastname: Bergeron
authors.forename: Pat
authors.initials: P
authors.lastname: Soutter
authors.forename: Deirdre
authors.initials: D
authors.lastname: Lyons
authors.forename: Jack
authors.initials: J
authors.lastname: Cuzick
mesh_terms: D000328:Adult; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D005838:Genotype; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods; D009693:Nucleic Acid Hybridization / Q000379:methods; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics*; D030361:Papillomavirus Infections / Q000821:virology*; D011237:Predictive Value of Tests; D012372:ROC Curve; D012680:Sensitivity and Specificity; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology*
chemical_list: D004279:DNA, Viral